Internal Limiting Membrane Peeling in Proliferative Diabetic Retinopathy

Not Applicable

Active, not recruiting

• Conditions: Diabetic Retinopathy Visually Threatening
• Interventions: Procedure: ILM Peeling; Procedure: No ILM Peeling

• Registration Number: NCT04380064
• Lead Sponsor: Rush Eye Associates

Brief Summary

Subject/Participant Groups:

Study Group: Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment Control Group: Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment

Detailed Description

Hypothesis:

Subjects undergoing ILM peeling during vitrectomy will have lower central macular thickness on OCT, fewer postoperative epiretinal membranes, and thereby better final visual acuity to control subjects Randomization: Subjects will be randomized according to a coin toss during PPV, once Grade 2 or Grade 3 vitreoretinal adhesion has been determined: heads undergo ILM peeling, while tails do not.

Number of Subjects: With study power of 80%, a significance level of 0.05, a sample size of 60 patients for each group was calculated.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-15
• Last Update Posted: 2023-11-18
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	ILM Peeling	Subjects undergo internal limiting membrane (ILM) peeling during vitrectomy for the indication of tractional retinal detachment
Control Group	No ILM Peeling	Subjects do not undergo ILM peeling during vitrectomy for the indication of tractional retinal detachment

Primary Outcome Measures

Name	Time	Method
Postoperative ERM Development	6 months	Postoperative Epiretinal Membrane Development

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	6 months	Rate of subjects achieving 20/50 or better Snellen visual acuity

Trial Locations

Locations (1)

Hospital La Carlota; 🇲🇽 Montemorelos, Nuevo Leon, Mexico